Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
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|ClinicalTrials.gov Identifier: NCT00315081|
Recruitment Status : Unknown
Verified November 2005 by University Hospital, Bonn.
Recruitment status was: Not yet recruiting
First Posted : April 17, 2006
Last Update Posted : April 17, 2006
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Hyperprolactinemia||Drug: Bromocriptin||Phase 3|
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Depending on its concentration hyperprolactinemia causes a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in men by inhibiting the pulsatile GnRH-secretion.The hyperprolactinemia-induced symptoms have been successfully medicated for years with dopamine agonists like bromocriptine.
In patients with psychiatric diseases hyperprolactinemia is usually not treated with dopamine agonist fearing a reexacerbation of the underline psychiatric disease. In a few studies and casuistically the treatment of neuroleptic-induced hyperprolactinemia with bromocriptine has been shown to be effective without causing reexacerbation of psychotic symptoms.
Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia (in extremis galactorrhoea and amenorrhoea. in women, loss of libido and erectile dysfunction in men) will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones (prolactin, LH, FSH, testosterone, estradiol). In case of a clear symptomatic, neuroleptic-induced hyperprolactinemia patients will be medicated with bromocriptin. Therapeutical success will be determined endocrinologically in week 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 together with a psychiatric examination (PANSS, HAM-D, Simpson-Angus Scale (SAS)). Safety of therapy will be ensured by the close meshed psychiatric examinations.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia|
|Study Start Date :||May 2006|
|Study Completion Date :||May 2008|
U.S. FDA Resources
- Simpson Angus Scale (SAS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315081
|Contact: Kai-Uwe Kuehn, MD||0049-(0)email@example.com|
|University of Bonn, Department of Psychiatry||Not yet recruiting|
|Bonn, Northrhine-Westfalia, Germany, 53105|
|Contact: Kai-Uwe Kuehn, MD 0049-(0)2228-287-5681 firstname.lastname@example.org|
|Principal Investigator:||Wolfgang Maier, MD||University of Bonn, Department of Psychiatry|